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CBZ

Model TD3416 · RANDOX LABORATORIES LIMITED · DI 05055273206463

KLT — Enzyme Immunoassay, Carbamazepine · Class II · 21 CFR 862.3645

UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

23562019-01: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 6/device2023-11: 0 reports for this device; peer average 6/device2024-03: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 1.33/device2025-12: 0 reports for this device; peer average 3/device0108091012040204061103020512
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0801
2019-0901
2019-1001
2019-1201
2020-0401
2021-0202
2022-0401
2022-0606
2023-1106
2024-0302
2025-0202
2025-0501.33
2025-1203
This device (reports/month)Average device in KLT (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — RANDOX LABORATORIES LIMITED

  • Warning Letter 2024-12-06 Randox Laboratories Limited
  • Warning Letter 2024-12-06 Randox Laboratories Limited
  • OAI 2024-08-08 Randox Laboratories Limited · 0 citations
  • OAI 2024-08-08 Randox Laboratories Limited · 0 citations
  • VAI 2016-04-28 Randox Laboratories, Limited · 1 citations
  • VAI 2016-04-28 Randox Laboratories, Limited · 1 citations
  • VAI 2016-04-28 Randox Laboratories, Limited · 1 citations
  • VAI 2016-04-28 Randox Laboratories, Limited · 1 citations
  • VAI 2016-04-28 Randox Laboratories, Limited · 1 citations
  • VAI 2016-04-28 RANDOX LABORATORIES, LTD. · 1 citations
  • VAI 2013-12-05 RANDOX TEORANTA · 2 citations
  • VAI 2012-11-29 Randox Laboratories, Limited · 5 citations
  • VAI 2012-11-29 Randox Laboratories, Limited · 5 citations